Kentucky libertarian Sen. Rand Paul was not entirely successful with his amendments to the Food and Drug Administration (FDA) User Fee Reauthorization Bill before it passed the Senate Thursday by a 96 to 1 vote.
The bill, setting user-fees to provide about half of FDA’s $4.5 billion budget for next year, showed the Senate can fully debate, amend and pass a needed law.
Paul was fully engaged in the process with multiple amendments. One – to disarm FDA agents, stop raids on natural food stores and Amish farms and end the agency’s scrutiny of truthful claims for dietary supplements – received only 15 votes.
But Paul did get his language included in the bill that forces FDA to accept data from clinical investigations conducted outside of the U.S., including the European Union, because Paul says it will speed getting life-saving drugs to the market.
Paul hailed passage of the bill because it contained some of his words.
“Innovation in clinical drug trials should not be confined to the data received from trials in the United States. Findings from countries that incorporate the same rigorous requirements as we do when developing life-saving drugs and devices should be accepted by the FDA as well,” Paul said. “I am proud to see this important step being taken to increase the treatment options of millions of Americans currently hampered by outdated laws.”
But Paul clearly had much enthusiasm for amendment No. 2143, which he lost.
“I think we have too many armed federal agencies, and that we need to put an end to this,” Paul said, adding that criminal law is increasingly being used as a tool by the “government bureaucracy to punish and control honest businessmen for simply attempting to make a living.”
“Historically the criminal law was intended to punish only the most horrible offenses that everyone agreed were inherently wrong or evil, offenses like rape, murder, theft, arson – but now we’ve basically federalized thousands of activities and called them crimes,” he continued. “If bureaucrats need to involve the police, let’s have them use the FBI, but I see no reason to have the FDA carrying weapons.”
Most “raids” involving FDA are seizures and searches conducted by the U.S. Marshals Service, who are charged with implementing federal court orders. FDA’s Office of Criminal Investigations is an armed federal police force created by Congress in 1992.
Paul’s amendment also would have added the words “knowing” and willful” into various prohibited acts regulated by FDA. The effect would have been to make it more difficult to bring prosecutions.
A third section would have prevented FDA from curbing the marketing of dietary supplements with unproven claims about mitigative and curative effects.
The Kentucky senator is the son of Texas Congressman Ron Paul. Like his father, he is also a medical doctor, practicing as a ophthalmologist and eye surgeon for 18 years before winning election to the Senate.© Food Safety News